JP5548203B2 - Powder inhaler - Google Patents

Description

  The present invention relates to powder inhalers, and more particularly to dry powder inhalers.

  Inhalers are known in the prior art and various types exist. First, there is an inhaler of a type in which a plurality of doses (a dose is a fixed amount to be administered per driving) are stored in one storage container. This inhaler is provided with a metering means, so that each time it is driven, the powder can be taken out from the storage container by one dose and carried to the discharge duct for administration to the user. An inhaler having a plurality of individual storage containers (such as capsules) and loading one storage container immediately before use is also disclosed in the prior art. The advantage of such a device is that it is not necessary to store the entire dose inside the instrument, so that the instrument can be made smaller. However, such an inhaler is troublesome in use. This is because the user is forced to load the capsule into the inhaler every time before use.

  And as the next type, powders for multiple doses are pre-divided into one dose (predose) and packed in individual storage containers, and one storage container is opened each time the inhaler is driven. There is. In this form of implementation, the powder can be sealed more effectively because each dose is opened only when it is about to release it. Various techniques for making such individual storage containers have already been proposed, such as an elongated blister strip or a blister placed on a rotating circular disk.

  All of the existing types of inhalers, including those described above, have both advantages and problems related to structure and type of operation. That is, there is a problem regarding the reproducibility and accuracy of measurement for each drive in a specific inhaler. In addition, in some inhalers there is also a problem of administration efficiency. The efficiency of administration is the proportion of the effective portion that enters the user's lungs within one dose and exhibits a beneficial therapeutic effect. One solution to these specific problems is to synchronize dose release with the patient's inhalation behavior.

  However, this can still cause problems. Specifically, in this type of device, a dose is usually placed in the discharge duct before the inhalation operation, and the discharge is synchronized with the subsequent inhalation operation. That is, the user drops or shakes the inhaler between the time when the user loads the dose (from multiple dose storage containers or individual storage containers) and the time when the inhalation operation is performed, or is an undesirable way or inappropriate If operated in such a way, there is a risk that all or part of the dose will be scattered inside the device and will remain undosed. Also, if this happens, there is a high risk that overdose will occur the next time the device is used. A user who recognizes that the entire dose could not be dispensed will load the device with a new dose. When the newly loaded dose is inhaled, the portion of the previous dose scattered in the device may be released at the same time as the new dose, resulting in overdose. Such overdose can be very detrimental to the envisaged therapy. As a result, supervisors in all countries are now trying to tighten regulations to minimize the risk of overdose.

With regard to opening individual storage containers, methods for peeling off or peeling off the sealing layer have been proposed. For that, especially when it is necessary to drive the opening means by suction, it is necessary to control the applied force to ensure complete opening while avoiding the risk of opening to subsequent storage containers. The problem is that it is difficult to control.
Regarding the means for administering the powder in a finely crushed state, as disclosed in US Pat. No. 6,715,486, one or more small spheres are placed in a dispersion chamber, In addition to rotating the globules, there is one in which the powder is sent from the opened storage container to the dosing opening. If such a dispersion chamber is used, the powder that has become a mass can be crushed and made sufficiently fine, and the resistance to air flow can be reduced.

  However, the effect of the dispersion chamber containing the spheres is relatively susceptible to the orientation of the inhaler during inhalation. If the orientation is not optimal, i.e. if the inhaler is not held in a vertical orientation, it can be affected with respect to properties such as effects, variability, resistance, etc. In addition, the use of small spheres complicates the assembly operation, thereby increasing costs.

International Publication No. 01/26720 French Patent Invention No. 2 881 117 French patent invention No. 2 909 641 International Publication No. 2007/118490 US Pat. No. 5,469,843

An object of the present invention is to provide a fluid dispenser device, particularly a dry powder inhaler, in which the above problems do not occur.
Specifically, an object of the present invention is to provide the following inhaler. That is, it is easy and inexpensive to manufacture and assemble, has high reliability in use, can guarantee the accuracy of measurement and the reproducibility of measurement in every drive, and has a large dose at the site to be treated (especially the lung). By allowing the part to be administered and avoiding the risk of overdosing in a safe and effective manner, it provides the best results in terms of treatment efficiency, is as small as possible while at the same time leading to release An inhaler that ensures that all doses are sealed and held intact.

  It is another object of the present invention to provide an inhaler capable of guaranteeing high accuracy and reproducibility regardless of the direction of the inhaler for metering performed each time.

In order to achieve the above object, the present invention provides a powder inhaler, which is a main body having an administration opening, a plurality of storage containers in which powders to be administered are preliminarily stored by one dose, A storage container opening means for opening one storage container at a time, and the storage container opening means is configured to open a hole in one storage container in which one dose is stored in advance each time it is driven. A perforating means having a pointed member, connected to the perforating means, having an inlet for receiving a dose of powder from an opened storage container, and an outlet connected to the dosing opening And the punching means is controlled by the user's inhalation operation. As a result, one storage container storing one dose in advance is opened and the contents are taken out and taken out at the same time. powder the dispersion flow path Carried by the inhalation flow passing through and released from the administration opening, the dispersion channel has two bent channel parts, and the first bent channel part passes through the first straight channel part. Connected to the inlet, the second bent channel portion is connected to the outlet via a second linear channel portion, and the two bent channel portions are connected to the third linear channel portion. The powder inhaler is provided such that the cross-sectional area of the third linear flow path portion is smaller than the cross-sectional area of the first linear flow path portion.

In addition, it is effective that the first linear flow path portion and the second linear flow path portion are parallel to each other.
In addition, it is effective that the angle formed by the first bent channel portion is 90 degrees or more, and preferably 100 degrees.
In addition, it is effective that the angle formed by the second bent flow path portion is 90 degrees or more, and preferably 100 degrees.

Further, it is effective that the dispersion channel is composed of a base portion and a lid portion.
The inlet and the first linear channel portion of the dispersion channels are formed by a base, and the outlet and the second linear channel are formed by a lid. It is effective that the two bent flow path portions and the third linear flow path portion are formed by both the base portion and the lid portion.

In addition, at least one of the first linear flow path portion, the second linear flow path portion, and the third linear flow path portion has a constant cross-sectional area in the length direction. It is effective.
In addition, it is effective that the second linear flow path portion has a narrowing means.
The foregoing and other features and advantages of the present invention will become apparent from the following detailed description, given by way of non-limiting example, with reference to the accompanying drawings.

It is a schematic sectional drawing of a powder inhaler. It is a schematic perspective view which expands and shows a part of inhaler by one of the embodiments. It is a figure similar to FIG. 2, and is a figure which shows effective embodiment of this invention. It is a schematic longitudinal cross-sectional view which shows a part of inhaler of FIG.

  Illustrated in FIG. 1 is an example of an effective embodiment of a dry powder inhaler. The inhaler has a main body 10 to which two cap components (not shown) can be attached in a slidable or pivotable state, the device is opened by opening the cap, At the same time, the device is preloaded. The body 10 is nearly circular in shape, but could be any other suitable shape. The main body 10 has a mouthpiece or an inhalation end formed with an administration opening 15, and the user inhales from the administration opening 15 when the apparatus is driven. The cap can be opened by rotating the two cap components around a common rotation axis. However, it is possible to consider other means for opening the device. As a variant, it would be possible to have one cover instead of two.

  A strip (not shown) having a plurality of individual storage containers (also called blisters) is arranged inside the main body 10. The strip is made as an elongated flexible strip in which a plurality of blisters are arranged in a known manner. In the stage before the first use, the blister strip is wound inside the body 10, preferably in the storage part. And the 1st moving means is provided in order to move the strip 30, The said 1st moving means expand | deploys a blister strip gradually, and advances it. Second moving means 50, 51 are also provided to carry one blister or storage container to the administration position each time the device is driven. As an effective configuration, the part of the strip where the storage container is emptied is made to be wound around another part of the body 10, preferably a storage part.

  The inhaler has a storage container opening means 80, which is shown only very schematically in FIG. 1 but can be seen in more detail in FIGS. As a perforation / cutter means for perforating or cutting through the sealing layer of the blister. For example, as an effective configuration, the storage container opening means comprises a pointed member. It is preferable that the tip member does not move with respect to the main body 10, and each time it is driven, one blister is moved by the second moving means and pressed against the tip member. Drilling is performed in such a manner that the pointed member enters the blister, and the powder is released by the suction force generated by the user's suction operation.

  The first moving means is configured to advance the blister strip at a timing before driving, during driving or after driving each time the apparatus is driven. During the driving, the second moving means moves the storage container from which the contents are to be taken out and presses it against the punching / cutter means. The second moving means can be biased by the force of the elastic element 510 (spring or some other equivalent elastic element) via the pressing means 800, and the elastic element is compressed in advance when the device is opened. It becomes the composition which is done.

  In a preferred configuration, the first moving means comprises an indexer wheel 30 that houses and guides the blister. The blister strip is advanced by the rotation of the indexing wheel. In a certain angular position, one of the storage containers is always in a position facing the storage container opening means. The second moving means has a rotation support element 50 that rotates about a rotation shaft 51, and the indexing wheel 30 can be attached to the rotation support element in a rotatable manner.

  The drive cycle of the device is as follows. When the device is opened, the two cap-forming side portions pivot on the body and move away so that the device is opened and the device is stressed. In this state, the second moving means is held by suitable blocking means 100, 110, so that the indexing wheel cannot be moved toward the tip member. As a preferred configuration, while the user performs an inhalation operation from the mouthpiece, the blocking means is released and the support element 50 is rotated, whereby the indexing wheel 30 is moved toward the pointed member and stored. The container will be opened.

The optimal orientation of the inhaler when in use is the orientation in which the administration opening 15 is in an upward state, as shown in FIG. However, the inhaler according to the invention can be used in any state.
As explained above, the storage container opening means is preferably driven by the user's inhalation operation. An inhalation activation system is provided for activating the storage container opening means by an inhalation operation, and the inhalation activation system comprises, as an effective configuration, a unit 60 that can be moved or deformed by the action of the inhalation operation, The blocking means 100 and 110 are configured to be released via a rod 101. The unit is advantageously composed of a deformable air chamber 61. When the deformable air chamber is deformed by a user's inhalation operation and thereby the blocking means is released, the second moving means is moved to move one of the storage containers toward the opening position. It becomes possible. Thereby, the storage container is opened just at the time of the inhalation operation, and the contents are taken out at the same time. Therefore, there is no risk that a part of the dose is lost between the time when the storage container is opened and the time when the contents are taken out.

  In the modified example, other inhalation starting means can be used, and for example, a valve flap capable of rotating movement can be used. The valve flap is rotated by the action of the suction force generated by the suction operation during the user's suction operation, and the blocking means that has stopped the movable support means is released by the rotation motion, and as a result, the storage container is opened Moved towards the means.

When the user closes the device after the inhalation operation, all the components return to their initial positions (rest positions). The device is then ready for the next use cycle.
The inhaler of the present invention has a dispersion flow path 70 for receiving a dose of powder taken out of one storage container. The dispersion channel 70 has an inlet 710 directly connected to the storage container opening means and an outlet 720 directly connected to the administration opening 15. In other words, there is a component called a dispersion chamber between the inlet 710 and the outlet 720 of the dispersion channel and between the perforating means 80 and the administration opening 15 (with a sphere inside). It ’s not provided). When mounted in this way, the manufacture and assembly of the device is simplified.

In the example shown in FIG. 2, a straight flow path is seen between the inlet 710 and the outlet 720. As an effective configuration, the cross-sectional area of the dispersion channel 70 is substantially constant over the entire length direction of the channel.
The dispersion channel 70 has at least one first bent channel portion 71, and the first bent channel portion 71 is connected to the inlet 710 through a first linear channel portion 67. Yes. The cross-sectional area of the first linear flow path portion 67 is preferably constant in the length direction. Further, as an effective configuration, the dispersion channel 70 further includes a second bent channel portion 72, and the second bent channel portion 72 passes through the second straight channel portion 68. It is connected to the exit 720. It is also preferable that the cross-sectional area of the second linear flow path portion 68 is also constant.

  Examples of these two bent flow channel portions are shown in FIGS. The two bent flow channel portions 71 and 72 can be connected to each other via a third linear flow channel portion 69, and the cross-sectional area of the third linear flow channel portion 69 is also constant. It is preferable to do this. The cross-sectional area of the third linear flow path portion 69 in the present invention is smaller than the cross-sectional area of the first linear flow path portion 67. As a result, a mixed flow of air and powder passing through the inside is obtained. Accelerated. As a modified example, as shown very schematically in FIG. 1, the third linear flow path portion 69 has a shape in which the cross-sectional area increases toward the second bent flow path portion 72. You can also. Further, the cross-sectional area of the second linear flow path portion 68 may be the same as the cross-sectional area of the first linear flow path portion 67 as seen in FIG. The second linear channel 68 may also have constriction means 725, for example in the form of one or more protrusions protruding inside. The constriction means 725 breaks the powder lump by disturbing the mixed flow of air and powder. What is necessary is just to optimize about the dimension and cross-sectional area of each flow path part according to arrangement | positioning of various components which comprise an inhaler, and the performance calculated | required.

  As an effective configuration, the angle formed by each of the two bent flow passage portions 71 and 72 is 90 degrees or more, and is preferably about 100 degrees. As seen in FIGS. 3 and 4, the first linear flow path portion 67 and the second linear flow path portion 68 are substantially parallel, and the third linear flow path portion 69 is It is slightly inclined between the two bent flow path portions 71 and 72. As a result, the ratio of the portion of the powder originally stored in the storage container to the outlet 720 of the dispersion channel 70 exceeds 95%, and the efficiency becomes very high. Furthermore, the measurement reproducibility when driven continuously is very excellent. Naturally, the performance of the inhaler can be maximized by optimizing the size and orientation of each flow path portion in accordance with the characteristics of the inhaler.

  As an effective configuration, the dispersion channel 70 includes a base 701 and a lid 702. Moreover, as a preferable configuration, the inlet 710 and the first linear flow path portion 67 are formed by only the base portion 701 as seen in FIGS. Similarly, the outlet 720 and the second linear flow path portion 68 are formed of only the lid portion 702 as a preferable configuration. The two bent flow channel portions 71 and 72 and the third linear flow channel portion 69 are formed by both the base portion 701 and the lid portion 702 as a preferable configuration. Such a configuration facilitates molding and assembly.

As described above, according to the present invention, a dry powder inhaler that performs the following functions can be provided. These functions are
• Store multiple doses of powder at a dose in separate sealed storage containers (eg, store 30 or 60 doses in a rolled strip).
• Release the powder by drilling performed by the user's inhalation action (perforating the blister is performed using an inhalation detection system coupled to a pre-powered release system).
• Engage the appropriately shaped drive means to move the blister strip each time it is driven and bring the new storage container to the position where it will be opened by the appropriate opening means.
-Effectively disperse the powder before release to reduce the amount of powder left when the direction of inhalation is not optimal, and to reliably increase the accuracy and reproducibility of metering at each drive.

  The apparatus of the present invention described herein also provides functions other than those described above. It should be noted that although various embodiments of the inhaler are shown as providing a plurality of different functions simultaneously, these functions can be implemented separately. Specifically, for the inhalation activation system, regardless of the type of storage container opening means, whether or not a dose indicator is used, how individual storage containers are arranged relative to each other, and the shape of the dispersion chamber, etc. Can be used. Also, the means for completing the operation preparation and the inhalation activation system can be made in another form. The same applies to the other components of the device.

  Moreover, those skilled in the art will be able to devise various modifications without departing from the scope of the invention as defined by the appended claims.

Claims (8)

A powder inhaler,
A body (10) with an administration opening (15);
A plurality of storage containers in which powders to be administered are stored in advance at a dose;
Storage container opening means (80) for opening one storage container each time it is driven,
The storage container opening means is a punching means having a pointed member made so as to open a hole in one storage container in which 1 dose is stored in advance each time it is driven,
An inlet (710) connected to the piercing means (80) for receiving a dose of powder from an opened storage container and an outlet (720) connected to the dosing opening (15); A dispersion channel (70) having
The perforating means is controlled by the user's inhalation operation. As a result, one storage container in which 1 dose is stored in advance is taken out and the contents are taken out at the same time, and the taken out powder is the dispersion channel. Carried by the inhalation flow through and released from the dosing opening,
The dispersion flow path (70) has two bent flow path portions (71, 72), and the first bent flow path portion (71) passes through the first straight flow path portion (67). The second bent channel portion (72) is connected to the outlet (720) via a second linear channel portion (68), and is connected to the inlet (710). The flow path parts (71, 72) are interconnected via a third linear flow path part (69),
The cross-sectional area of the third linear channel portion (69) is smaller than the cross-sectional area of the first linear channel portion (67);
Powder inhaler characterized by. The first linear channel portion (67) and the second linear channel portion (68) are parallel;
The powder inhaler according to claim 1. The angle formed by the first bent channel portion is 90 degrees or more, preferably 100 degrees,
The powder inhaler according to claim 1 or 2, wherein The angle formed by the second bent channel portion is 90 degrees or more, preferably 100 degrees,
The powder inhaler according to any one of claims 1 to 3, wherein: The dispersion channel (70) is composed of a base (701) and a lid (702);
The powder inhaler according to any one of claims 1 to 4, wherein: The inlet (710) and the first linear channel portion (67) of the dispersion channel (70) are formed by the base (701),
The outlet (720) and the second linear flow path portion (68) are formed by a lid portion (702),
The two bent flow path portions (71, 72) and the third linear flow path portion (69) are formed by both a base portion (701) and a lid portion (702);
The powder inhaler according to claim 5. At least one of the first linear channel (67), the second linear channel (68), and the third linear channel (69) has a constant cross-sectional area in the length direction. There is,
The powder inhaler according to any one of claims 1 to 6. The second linear flow path portion (68) has constriction means (725);
The powder inhaler according to any one of claims 1 to 7, wherein

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